W4TR06 Solara Quad CRTP MRI SureScan
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
W4TR06 Solara Quad CRTP MRI SureScan
Information

Device Survival Probability

W4TRXX_SURV
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    at 4.0 mo                  
% Excluding Normal Battery Depletion 100.0                  
% Including Normal Battery Depletion 100.0                  
#   379                  
  • Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
  • Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type CRT-Pacing
NBD Code OAE-DDDR
Max. Delivered Energy N/A
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Serial Number Prefix RNZ
Mass 30 g
Volume 20.5 cc
Waveform N/A
X-Ray ID RNP
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Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 8.7 10.9
Nominal 3.5 V (A, RV) 6.9 8.5
High 5.0 V (A, RV) 3.9 6.0
Footnote

Longevity estimates based on the following device usage.   Pace/Sense Mode DDD ; Atrial Pulse Width 0.4 ms; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Left Ventricle Pulse Width 0.4 ms; Left Ventricle Pulse Amplitude same as A, RV; Left Ventricle Percent Paced 100 %; Left Ventricle Lead Impedance same as A, RV; EGM Prestorage ON ; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 % Hide this content

Information

EOS Indication

6 months after RRT

Information

Distribution Data

US Market Release
CE Approval Date2017-02-10
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2017-02-10
Estimated WW Distribution421
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Recommended Replacement (RRT)

180 days after 3 consecutive daily automatic measurements of ≤ 2.63 V or immediately after 3 consecutive daily automatic measurements of ≤ 2.60 V, whichever comes first

Data as of July 31, 2017

www.medtronic.com/productperformance 501050